Lead Biostatistician, Analytical Validation

This is a fully remote position, open to applicants in California.

📋 Description

• Take charge of the design, analysis, and interpretation of analytical validation studies for oncology products independently.

• Act as the statistical lead on several high-priority project teams.

• Collaborate with bench scientists, bioinformatics experts, and product development teams to incorporate statistical knowledge into project planning and execution.

• Develop detailed protocols and reports for cross-functional collaborators and stakeholders.

• Ensure that statistical methodologies and analyses conform to the standards established by regulatory bodies such as CAP/CLIA, NYS, and the FDA.

• Lead the application of both conventional and advanced statistical methods for studies of various complexities.

⛳️ Requirements

• A minimum of 5 years (for Lead) or 8 years (for Staff) of pertinent industry experience, particularly in analytical validation within diagnostics, biotechnology, or similar sectors.

• A Ph.D. or Master’s degree in Biostatistics, Statistics, or a related discipline.

• In-depth knowledge of statistical methodologies in diagnostic medicine, including a thorough understanding of CLSI guidelines.

• Outstanding written and verbal communication abilities, especially in conveying information to non-technical executive leadership.

• Proven capability and enthusiasm for collaborating on cross-functional teams with individuals from diverse technical backgrounds.

• Excellent problem-solving skills and meticulous attention to detail.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.

• Complimentary testing for employees and their immediate families.

• Fertility care benefits.

• Leave for pregnancy and bonding with a baby.

• 401k benefits.

• Commuter benefits.

• A generous employee referral program!